ICH Q3A Impurities in New Drug Substances
GPTKB entity
Statements (21)
| Predicate | Object |
|---|---|
| gptkbp:instanceOf |
Tourism
|
| gptkbp:appliesTo |
new chemical entities
|
| gptkbp:compatibleWith |
biological or biotechnological products
|
| gptkbp:documentType |
Tourism
|
| gptkbp:firstIssueDate |
1995
|
| gptkbp:focusesOn |
impurities in new drug substances
|
| gptkbp:guidanceSystem |
identification of impurities
qualification of impurities reporting of impurities |
| https://www.w3.org/2000/01/rdf-schema#label |
ICH Q3A Impurities in New Drug Substances
|
| gptkbp:issuedBy |
gptkb:International_Council_for_Harmonisation_of_Technical_Requirements_for_Pharmaceuticals_for_Human_Use
|
| gptkbp:language |
English
|
| gptkbp:referenceNumber |
ICH Q3A(R2)
|
| gptkbp:relatedTo |
ICH Q3B Impurities in New Drug Products
|
| gptkbp:updated |
2002
2022 |
| gptkbp:usedBy |
pharmaceutical industry
regulatory authorities |
| gptkbp:website |
https://www.ich.org
|
| gptkbp:bfsParent |
gptkb:ICH
|
| gptkbp:bfsLayer |
6
|